FDA Topics

• Overview of FDA Requirements for Regulated Industries: A Technical Track
• Auditing Microbiological aspects of Manufacturing in Pharmaceuticals, Medical Device and Biotechnology
• Preparing for Regulatory Inspections
• Clinical Trials: Three critical dimensions of Success
• Establishing a Contamination Control Program for FDA Regulated Industry
• Executing Mock Audits and Preparing for Regulatory Inspections
• Introduction to BioPharma
• Lyophilization For Biologics
• Corrective & Preventive Actions CAPA
• Creating and Maintaining Effective Records and Documentation
• Customers in Healthcare - Challenges in Making and Selling Medical Products
• Returned Product Disposition
• Establishing Compliant and Effective Document Control Systems for FDA Regulated Industry

Manufacturing Topics

• Project Management Foundations and Best Practices
• Project Risk Management
• Principles of LEAN Manufacturing 
• LEAN 5S
• LEAN Value Stream Mapping
• Advance Data Analysis
• Applying Statistical Process Control
• Design of Industrial Experiments: Part I Getting Started with DOE
• Design of Industrial Experiments: Part II System Optimization Using
• Measurement Systems Analysis
• Practical Data Analysis
• cGMP Clean-in-Place (CIP)
• Basic SPC for Technicians & Operators
• Optimizing Your Supply Chain - Best Practices for Small and Medium Enterprises
• Production & Process Control

Communication Topics

• Collaborative Skills for Teams
• Customer Satisfaction Skills
• Effective Negotiation Skills
• Effective Presentation Skills
• Emotional Intelligence in the Workplace
• Enhancing Communication by Understanding Yourself and Others
• Technical Writing & Documentation within the FDA Regulated Environment

Management Topics

• Frontline Management: Leveraging the Strengths of Your Style
• Integrated Commissioning & Qualification
• Managing an Effective Quality System
• Management of Cleanrooms in FDA Regulated Industry
• Facility Operation, Maintenance Programs, and Calibration
• Planning and Time Management for Supervisors
• Team Building, Diversity, Innovation, and Change